The Development and Initial Evaluation of a Web-based, Compassion-focussed Course for New Mothers

February 20, 2018 updated by: Canterbury Christ Church University
This study examines the relationship between self-compassion and wellbeing in new mothers and whether an online self-help course for new mothers can help to improve their wellbeing and self-compassion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomised controlled trial (RCT) comparing an online self-help course ('Kindness for Mums') with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 6) and at follow-up (week 12). Baseline data will also be used to examine the relationship between self-compassion and wellbeing.

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • New mothers (can be biological, adoptive or full-time foster mother)
  • Able to complete baseline measures when infant aged 0-12 months
  • Fluent in English
  • Live in the United Kingdom
  • Able to access the internet

Exclusion Criteria:

  • Experiencing suicidal ideation at the time of enrolment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kindness for Mums
An online self-help course designed to promote self-kindness and self-compassion in new mothers
Other: Kindness for Mums
No Intervention: Wait list control
A waiting list control group, who will receive access to the online self-help intervention once the RCT is complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline at 6-weeks on the Warwick-Edinburgh Mental Well-Being Scale
Time Frame: Post-intervention (i.e. 6-weeks after baseline)
Post-intervention (i.e. 6-weeks after baseline)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline at 6-weeks on the Self-Compassion Scale
Time Frame: Post-intervention (i.e. 6 weeks post baseline)
Post-intervention (i.e. 6 weeks post baseline)
Change from baseline at 6-weeks on the Forms of Self-Criticising/Attacking and Self-Reassuring Scale
Time Frame: Post-intervention (i.e. 6 weeks post baseline)
Post-intervention (i.e. 6 weeks post baseline)
Change from baseline at 6-weeks on the Depression, Anxiety and Stress Scale 21-item version
Time Frame: Post-intervention (i.e. 6 weeks post baseline)
Post-intervention (i.e. 6 weeks post baseline)
Change from baseline at 12-weeks on the Warwick-Edinburgh Mental Well-Being Scale
Time Frame: 12-weeks after baseline
12-weeks after baseline
Change from baseline at 12-weeks on the Self-Compassion Scale
Time Frame: 12-weeks after baseline
12-weeks after baseline
Change from baseline at 12-weeks on the Forms of Self-Criticising/Attacking and Self-Reassuring Scale
Time Frame: 12-weeks after baseline
12-weeks after baseline
Change from baseline at 12-weeks on the Depression, Anxiety and Stress Scale 21-item version
Time Frame: 12-weeks after baseline
12-weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canterbury Christ Church University

Investigators

  • Principal Investigator: Isobel Gammer, BA, MSc, Canterbury Christ Church University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

May 11, 2017

Study Completion (Actual)

May 11, 2017

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IsobelGammerMRP2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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